FDA flags potential safety risk for Lilly antipsychotic drug

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Dive Brief:

The Food and Drug Administration on Tuesday warned of rare, but serious serious side effect risks for the antipsychotic olanzapine, mandating an update to the drug's safety label. In some cases, olanzapine can cause a sometimes fatal skin reaction known collectively as drug reaction with eosinophilia and systemic symptoms.

Now generic, olanzapine is also marketed under the brand names Zyprexa and Symbyax by Eli Lilly.

Since the drug's first approval in 1996, the FDA has recorded 23 cases of the skin reaction in patients worldwide, one of whom later died.

Dive Insight:

Zyprexa is indicated to treat both schizophrenia and bipolar disorder. It has been a major drug for Lilly, still bringing in $940 million in sales last year despite the presence of generics.

However, the U.S. market only accounted for $157 million of those sales. In Japan, Zyprexa recently lost patent exclusivity for its schizophrenia indication last December and will come off patent for the bipolar indication in April 2016. Two generics are already approved and should dent the $416 million Lilly earned in that market last year.

Drug reaction with eosinophilia and systemic symptoms (or DRESS) starts as skin rash and can spread across the body, leading to lymph node swelling and organ damage. Mortality rates are as high as 10%, according to the FDA.

In the fatal case of DRESS recorded by the FDA, the patient had been taking other medications which could have exacerbated the reaction.

There is currently no treatment for DRESS and the FDA recommends patients who experience similar symptoms to immediately seek medical care. The warning cautioned against discontinuing use of the drug without consulting a physician.